Haleem.com
Haleem, not a dish
I am J Haleem.
– Life Science Product Manager
Experienced in team building, mentoring, and leadership in geographically distributed culturally diverse environment. Strong domain acumen (Life Sciences – Bio Pharma, Medical Devices) to establish credibility with business stakeholders. Worked with product development team and business team to identify and position market offerings across life sciences value chain – R&D, Clinical Data Management, Pharmacovigilance, Commercial, Manufacturing, Regulatory and IT.
Product Management
Analytics
Audit and Inspection
Gen AI
My Passion
PV
• Managed and collaborated with an agile team comprising of PV product teams, vendors, offshore team and cross-functional teams (Clinical Data Management, Commercial, Quality, IT & Analytics).
• Conducted interviews with PV business stakeholders to maintain their pain points, user stories, roadmap, backlogs, business values and timelines.
• Proactively communicated the realistic and holistic product KPIs with the Senior Leadership Team during Quarterly business review, audits, system upgrades, change management and, CAPA.
• Collaborated with internal/external technical teams to shape the IT Service Management.
• Integrated and retired applications with innovative and high-impact solutions to reduce the Total Cost of Ownership and to increase ROI.
• Solicited Request for proposals, conducted Conference Room Pilots with stakeholders, negotiated pricing with vendors and approved SOWs and SOPs.
• Reduced infrastructure expenses by 35% by lifting and shifting systems from in-house to the vendor’s SaaS.
• I oversaw the robotic and manual delivery of 10,000 reports (both expedited and periodic) each year, effectively reducing operational cost while ensuring high quality deliverables.
• Worked with IQVIA to build an AI-based Social Media Intelligence for post-market surveillance
CDM
• Administration and helpdesk support of Oracle Life Science Applications (Oracle Clinical, Thesaurus Management System, and Oracle RDC), LIMS and, Source Data Verification for 500+ users globally for Clinical Systems (Clinical Data Management, Medical Coding & Dictionary Management, EDC and Informatica Data Warehouse applications).
• Troubleshooting, system testing, system administration, maintenance and, monitoring interfaces.
• Wrote validation/derivation procedures (edit checks), entire study startup database development and randomization using Oracle Clinical 4.0.7. Created data extract views, developing reports using Integrated review.
• I was in-charge of writing and validating Oracle Clinical 4.5 user acceptance test (UAT) cases for “Oracle Corporation”. These UAT includes DVGs, DCI and DCM layout generation and creating a model study at the Global Library
Volleyball
Windsor Athletic Club, Princeton, NJ
Education and Experiences
Master in Business Administration (MBA) – 2014
From – Annamalai University
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Bachelor of Science in Computer Science – 1993
From – Bharathidasan University
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry standard dummy text ever since the 1500s.
High School Leaving Certificate – 1990
From – Hameediah Higher Secondary School
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Associate Directory – 2020-2024
From – Merck & Co
Forecasting, IT budgeting, and compliance for a portfolio of GxP applications.
Assistant Director – 2019-2020
From – Bayer Healthcare
Liaison between Clinical Drug Safety Pharmacovigilance and other part of the organization.
Safety Data Manager – 2015-2019
From – Otsuka Pharmaceuticals
Identifying business solutions, validating, implementing, training, and supporting systems